
New MDCG guidance: Verification of Class D IVDs
4 April 2022What is the first FAQ question?
21 April 2022
A Notice to Stakeholders was released regarding the EU-Turkey Customs Union Agreement for medical devices. The gist of the document is that the same recognition under the Medical Device Regulation old Directives, also applies under the (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). Specifically, it confirms the following under the MDR/IVDR:
Authorized Representatives
- Confirms that European Economic Area manufacturers do not need an authorized representative to place devices onto the Turkish market, and vice versa.
- EU manufacturers must appoint an European Authorized Representative (EU AR). That EU AR can be located in the EEA or Turkey.
Notified Bodies
- Turkey is entitled to designate Notified Bodies to the MDR/IVDR.
- Turkish Notified Bodies have “the same rights and obligations as a notified body established in the EU.”
- Devices CE Marked via a Turkish Notified Body can circulate freely in the EEA, and vice versa.
The above is granted per Decisions Nos 1/95, 2/97 and 1/2006 of the ЕС-Turkey Association Council, followed by the EU-Turkey Customs Union Joint Committee statements of 21 May 2021 and 13 September 2021. Turkey is fully recognized under the medical device and IVD regulations.


